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1 Company Presentation 2015 Product availability mentioned in this presentation are subject to local regulatory approval
2 What makes DiaSorin a partner of choice Dedicated to content Constant Innovation Loyal to Customers DiaSorin offers the broadest range of specialty tests available in the immunodiagnostics market, and also soon in Molecular. DiaSorin continues to invest constantly in R&D leveraging its distinctive expertise in the field of Immuno and Molecular diagnostics to consistently deliver high quality assays improving laboratory efficiency. Direct and indirect global distribution with a strong commitment and network to serve customers worldwide. 2
3 DiaSorin: a pure player in Immunoassay Out of a ww Immunoassay market of 8bn, DiaSorin main clinical areas of focus are: OTHERS ONCOLOGY AND ENDOCRINOLOGY 26% 24% AUTOIMMUNITY 7% HEPATITIS AND RETROVIRUSES INFECTIOUS DISEASES 18% 14% 6,5% 4,5% GI STOOL TESTING BONE AND MINERAL %: percentage of WW Immunoassay market 3
4 Our history >40 years of value Continuous innovation, high-quality products and long-standing commitment to customers needs The Foundation DiaSorin s birth as division of Sorin Biomedica SpA Management Buyout, SpA 2013 Agreement with Roche Commercial expansion: Switzerland TODAY 1620 employees 2014 CLIA product expansion: Launch of Stool Diagnostic profile on LIAISON Systems Success and increase of Liaison XL installations WW expansion and consolidation of DiaSorin commercial presence Entrance in the Molecular Diagnostics market 2010 Launch of new Liaison XL system platform 2012 Acquisition of NorDiag, specialized in the extraction of nucleic acids Focus on molecular diagnostic: launch of the first product on LIAISON IXT and LIAISON IAM systems. Joint Venture DiaSorin - Trivitron in India 2007 >900 employees July 19, 2007: Stock market debut in the Italian Stock Exchange employees 2008 Acquisition of Biotrin, leader in Parvovirus Acquisition of Murex, entering blood bank market Commercial expansion: new subsidiares in Europe, Australia, South Africa DiaSorin buys from Eiken Chemical the license for the use of LAMP technology, dedicated to Molecular Diagnostics Acquisition of Byk Sangtec and rights to Liaison platform Products conversion from ELISA to CLIA New commercial branches (Mexico, Israel and China) CLIA portfolio expansion 4
5 DiaSorin worldwide presence Global presence with deep R&D expertise SUBSIDIARIES DISTRIBUTORS BONE & MINERAL STOOL DIAGNOSTIC HYPERTENSION FERTILITY (Steroids) USA Stillwater * R&D facility MOLECULAR IRELAND Dublin * R&D facility TUMOR MARKER THYROIDS FERTILITY (Hormones) GERMANY Dietzenbach * R&D facility MUREX ELISA UK Dartford INDUSTRIAL SITES 6 R&D FACILITIES 5 INDIPENDENT DISTRIBUTORS >80 COMPANIES WORLDWIDE 27 EMPLOYEES 1,620 COUNTRIES GROUP PRESENCE >60 ITALY Saluggia, Gerenzano INFECTIOUS DISEASE AUTOIMMUNITY ENDOCRINOLOGY * R&D facility SOUTH AFRICA Kyalami HEPATITIS C ELISA INDUSTRIAL SITES COMPANIES WORLDWIDE R&D FACILITIES 5
6 Knowledge is the challenge We believe in re search to develop innovative solutions to enhance efficiency. DiaSorin is committed to providing the highest quality assays for consistent patient care. BECAUSE THE MORE YOU KNOW, THE MORE YOU CAN DO. 6
7 R&D: main competencies & facts Molecular Diagnostics New Reagents New Technologies Assays Optimization Pre-industrialization ImmunoDiagnostics New Assay Prototypes New Technologies New Reagents Assays Optimization Pre-industrialization ImmunoDiagnostics Assays Optimization Pre-industrialization MOLECULAR Diagnostics New Reagents New Technologies FACTS 129 researchers worldwide ~6% of revenues invested 6/8 new immunoassays every year 2/3 new molecular assays every year 2/3 products redeveloped every year 7
8 Our Solutions
9 DiaSorin laboratory solutions Technologies to meet your needs ELISA Enzyme Linked ImmunoSorbent Assay CLIA ChemiLuminescence Immuno Assay Q-LAMP Liaison Instant Amplification Molecular Microplates automated systems dedicated to Blood Bank & Serology Laboratories A family of fully automated systems with the wide range of specialties A menu of specialties for Diagnostic Molecular Laboratories 9
10 Commitment to Molecular Diagnostic Become leader in Onco-haematology Leverage on the innovative DiaSorin Q-LAMP technology to change the paradigm of molecular diagnosis of leukemias Offer ultra rapid, simple and reliable solutions for a timely diagnosis of haematologic malignancies at the onset, improving management of urgencies Enlarge the portfolio, after the successfull launch of the first product Iam BCR-ABL Enter the field of therapy monitoring by developing quantitative solutions Consolidate the Infection Disease portfolio 6 products launched, for diagnosis and monitoring of infection diseases Consolidate the business in the european countries Improve penetration into de-centralized laboratories Expand the tactical nucleic acid extraction business Tactical sales of extraction products via OEM partners and third party distributors 10
11 Committed to efficiency You can count on us Objectives sharing Educational training Professional customer support World class service at the click of a mouse We speak easy, we speak green DiaSorin competence, professionalism and enthusiasm are our commitment to deliver excellence in your laboratory. 11
12 Liaison XL Innovation to meet your needs Compact design Liaison reagents quality Wide range of specialties High Throughput, up to 180 t/hour Easy to use & reliable System checks ensure quality results Point in space connectivity to LAS 12
13 Liaison XLine Streamline the process and improve the efficiency of your laboratory LIAISON XLine connects multiple LIAISON XL to Pre-Analytical modules offering the complete automation of the working process and a wide range of Immunoassays. Fully automated sample input and sorter module Sample decapper module Centrifuge module Flexible configuration 13
14 Liaison Systems Installed base evolution 5,872 3,641 4, , ,272 1,075 1,665 2,070 2,510 2,975 3,641 4,078 4,135 4,197 4,207 2,070 2,510 2, LIAISON LIAISON XL 14
15 DiaSorin, more than 100 assays menu Dedicated to content and counting... 15
16 The Liaison family collection menu Leading position in Specialty Assays AUTOIMMUNITY ANA Screen (2) dsdna (2) ttg IgA (2) ENA Screen (2) Cardiolipin IgG (2) Cardiolipin IgM (2) BONE & MINERAL 25-OH Vitamin D TOTAL N-TACT PTH Gen II 1-84 PTH Osteocalcin BAP OSTASE 1,25 dihydroxyvitamin D (1) FGF 23** Sclerostin** CARDIAC MARKERS Troponin I (2) Myoglobin (2) CK-MB (2) Endocrinology THYROID TSH (3rd Gen.) Free T3 Free T4 T3 T4 Tg Anti-Tg Anti-TPO REPRODUCTIVE ENDOCRINOLOGY LH FSH Prolactin Progesterone Testosterone Estradiol hcg/ß-hcg DHEA-S ADRENAL FUNCTION ACTH Cortisol GROWTH hgh IGF-I DIABETES C-Peptide Insulin HYPERTENSION Direct Renin Aldosterone Infectious disease SEPSIS SEPSIS BRAHMS PCT (2) BRAHMS PCT II Gen Chagas Chagas IgG TREPONEMA Treponema Screen EBV EBV IgM VCA IgG EBNA IgG EA IgG TORCH Toxo IgG Toxo IgM Toxo IgG Avidity Rubella IgG Rubella IgM CMV IgG CMV IgM CMV IgG Avidity HSV-1/2 IgG HSV-1 IgG HSV-2 IgG HSV-1/2 IgM Parvovirus B19 IgG Parvovirus B19 IgM BORRELIA Borrelia burgdorferi IgG Borrelia burgdorferi IgM VZV VZV IgG VZV IgM MYCOPLASMA Mycoplasma pneumoniae IgG Mycoplasma pneumoniae IgM MEASLES & MUMPS Measles IgG Measles IgM Mumps IgG Mumps IgM CHLAMYDIA Chlamydia t. igg Chlamydia t. iga Bordetella Bordetella pertussis Toxin IgG Bordetella pertussis Toxin IgA VIRAL HEPATITIS AND retroviruses HBsAg (2) HBsAg Quant (1) HBsAg Confirmatory test Anti- HBs II Anti- HBs II plus Anti- HBc HBc IgM HBeAg Anti-HBe Anti-HAV HAV IgM HCV Ab (1) HIV Ab/Ag (1) HIV Ab/Ag HT (1) HTLV I/II (1) Oncology TUMOUR MARKERS CEA Free PSA Total PSA CA 15-3 CA 125 II CA 19-9 TPA -M NSE S100 AFP hcg/ß-hcg Tg ß2-Microglobulin TK Calcitonin ANAEMIA Ferritin STOOL DIAGNOSTIC C. difficile GDH C. difficile Toxin A and B H. pylori SA EHEC (2) Rotavirus Adenovirus Calprotectin Campylobacter * Soon Available ** Under Development 1 - Available on LIAISON XL only 2 - Available on LIAISON only 16
17 Success Stories
18 DiaSorin leadership in Infectious Disease and Torch EUROPE Leadership in Infectious Disease with market share from 20 to 40% in ToRCH, EBV and other ID markers* USA Fully automated solution for disease testing and the first, fully automated MMRV CLIA panel CHINA First fully automated CLIA panel for the diagnosis of TORCH infections WORLDWIDE Parvovirus B19, EBV, HSV market leadership, in CLIA technology** SEPSIS SEPSIS BRAHMS PCT BRAHMS PCT II Gen Chagas Chagas IgG TREPONEMA Treponema Screen EBV EBV IgM VCA IgG EBNA IgG EA IgG TORCH Toxo IgG Toxo IgM Toxo IgG Avidity Rubella IgG Rubella IgM CMV IgG CMV IgM CMV IgG Avidity HSV-1/2 IgG HSV-1 IgG HSV-2 IgG HSV-1/2 IgM Parvovirus B19 IgG Parvovirus B19 IgM BORRELIA Borrelia burgdorferi IgG Borrelia burgdorferi IgM VZV VZV IgG VZV IgM MYCOPLASMA Mycoplasma pneumoniae IgG Mycoplasma pneumoniae IgM MEASLES & MUMPS Measles IgG Measles IgM Mumps IgG Mumps IgM CHLAMYDIA Chlamydia t. igg Chlamydia t. iga Bordetella Bordetella pertussis Toxin IgG Bordetella pertussis Toxin IgA * EDMA DATA **EDMA DATA AND INTERNAL DATA 18
19 DiaSorin leadership in Infectious Disease and Torch The broadest menu available in full automation bioplex immulite XPi architect cobas E vitros 3600 axsym unicel DXI - ACCESS advia centaur XP advia centaur CP TORCH Toxo IgG Toxo IgM Toxo IgG Avidity Rubella IgG Rubella IgM CMV IgG CMV IgM CMV IgG Avidity HSV-1/2 IgG HSV-1 IgG HSV-2 IgG HSV-1/2 IgM Parvovirus B19 IgG Parvovirus B19 IgM EBV EBV IgM VCA IgG EBNA IgG EA IgG BORRELIA Borrelia burgdorferi IgG Borrelia burgdorferi IgM 33 TREPONEMA Treponema Screen VZV VZV IgG VZV IgM MYCOPLASMA Mycoplasma pneumoniae IgG Mycoplasma pneumoniae IgM MEASLES & MUMPS Measles IgG Measles IgM Mumps IgG Mumps IgM CHLAMYDIA Chlamydia t. igg Chlamydia t. iga BORDETELLA Bordetella pertussis Toxin IgG Bordetella pertussis Toxin IgA Source: Companies websites 19
20 LIAISON XL: serology/virology menu The broadest consolidated Menu on the market Diasorin biomerieux siemens liaison Xl vidas advia centaur XP immulite XPi advia centaur cp abbott architect 2000 AxSYM roche cobas e BioRAD bioplex 2200 beckman ortho unicel dxi-access vitros eci/ Source: Companies websites id hep/retr/syphilis/chagas 20
21 Commitment to Hepatitis & Retroviruses (1) Murex and DiaSorin a history of science and technology HBV assays 1st HIV assay & HCV IP filing 1993 Murex acquires Wellcome 1995 HIV HTLV Syphilis 1998 Abbott acquires Murex 1999 HCV v 4.0 HBsAg, other HBV assays HIV Ag/Ab HAV IgM Anti-HBc HAV Total HDV 2004 HCV Type 2006 HCV Ag/Ab DiaSorin RIA & ELISA HBV (FDA) DiaSorin ELISA HCV HIV 1994 DiaSorin ELISA HIV tetra 1995 DiaSorin LIAISON HBV and HAV 2003 DiaSorin Launches LIAISON XL HCV, HIV HBsAg DiaSorin acquires Murex LIAISON XL HTLV I/II 2012 LIAISON XL CHAGAS 2013 LIAISON XL HIV HT
22 Commitment to Hepatitis & Retroviruses (2) Growing penetration in blood bank laboratories Quality of MUREX brand Synergic technology solution: ElIsa & CLIA Multiple platform Global presence with more than 700 blood banks NOT AVAILABLE IN US AND CANADA INTEGRAL MUREX 22
23 Hypertension The first company to fully automate the testing of Aldosterone and Direct Renin worldwide ~30% of the population are hypertensive (HTN) ~ 20% of hypertensive patients are RESISTANT HYPERTENSIVE (res-htn) >23% of Resistant HTN patients have Primary Aldosteronism Aldosterone Direct Renin Hypertension is affecting around 2 billion people worldwide, ~20% of those may suffer from resistant hypertension. The tests support in the diagnosis of primary and secondary hyperaldosteronism in patients with resistant hypertension. DiaSorin proudly introduced worldwide the two assays on its LIAISON systems, providing clinicians and labs with reliable, consistent and fast results. 23
24 25 years of worldwide leadership in Vitamin D DiaSorin (INCSTAR) introduced first 3H-based RIA. DiaSorin s RIA Vitamin D was the first FDA-cleared. LIAISON 25 OH Vitamin D was the first fully automated CLIA assay FDA cleared. LIAISON 25 OH Vitamin D TOTAL Assay was FDA cleared. Modified version of LIAISON 25 OH Vitamin D TOTAL assay released outside U.S. (FDA Cleared). Launch of 1,25 Dihydroxyvitamin D > FDA approved BEST-IN-CLASS Quality, Accuracy, Precision Assay of choice in top Labs WW (for example LabCorp, Sonic, ARUP, Quest) DiaSorin methods cited in most Vitamin D publications Continuous R&D investment to maintain leadership 24
25 LIAISON XL 1,25 Dihydroxyvitamin D Continuing worldwide leadership in Vitamin D testing First fully automated, extraction free First result in just 65 minutes More tests from the same patient tube (eg 25-OH Vitamin D, PTH) 25
26 Stool Testing Made easy Performe Stool testing menu in complete automation without quality compromise TEST MENU STOOL DIAGNOSTIC C. difficile GDH C. difficile Toxin A and B H. pylori SA EHEC Rotavirus Adenovirus Calprotectin Campylobacter 26
27
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